Swedish Board for Accreditation and Conformity Assessment MARS Bratislava, 24-26 September 2006 Anna Karlsson Special adviser Department of legal and public affairs.
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Swedish Board for Accreditation and Conformity Assessment MARS Bratislava, 24-26 September 2006 Anna Karlsson Special adviser Department of legal and public affairs SWEDAC - Accreditation - International cooperation - Designation of notified bodies - Market surveillance New Approach – necessary infrastructure • • • • • • • • Metrology Standardization Accreditation Authority to designate notified bodies Notified bodies Conformity assessment Sector authorities Market surveillance What is SWEDAC? • Public authority responsible to the - Ministry of Foreign Affairs - Ministry of Industry, Employment and Communication • National accreditation body • Central administrative authority - conformity assessment procedures - designation of notified bodies and conformity assessment bodies - coordination of market surveillance - legal metrology - precious metals Board Director-General Administrative Department Quality Control Economy Personnel Registry Internal service Marketing Technical Department Legal Department Regulations Market surveillance Legal metrology Legal advice Precious metals Conformity assessment Healthcare unit International Coordination International secretariat International & national projects Environment and Food unit Industry unit Technical Committees Vehicle unit Plants and Installations unit Certification unit Accreditation SWEDAC • the sole accreditation body in Sweden • fulfils the requirements in ISO/IEC 17011 • is member of EA, IAF, ILAC • issues regulations Act (1992:1119) and Ordinance (2005:894) on Conformity Assessment Accreditation Certification bodies Laboratories Inspection bodies Requirements in regulations based on EN and ISO standards Accreditation Certification bodies • products (EN 45011, ISO/IEC guide 65) • quality systems (EN 45012, ISO/IEC guide 62) • personnel (EN 45013) Laboratories (EN 17025) Inspection bodies (EN 17020) Accreditation The assessment – documentary and on site - includes • quality systems • administrative procedures • working methods • technical competence Annual surveillance, full re-assessment every 4th year International cooperation CA issues within EU, WTO, OECD, OIML Technical assistance Twinning Training Designation of notified bodies Act (1992:1119) and Ordinance (2005:894) on Conformity Assessment SWEDAC • the sole designating authority in Sweden • obligation to notify all private legal entities fulfilling the requirements Requirements in EN 45000 – ISO 17000 + relevant directives Designation of notified bodies Assessment procedure Dept. of legal affairs: • Legislation (directive, Swedish implementation, product group(s), module(s) • Independence • Impartiality • Economic stability • Liability assurance • Decision (Director-General) and notification to European Commission Dept. of technical affairs: Technical competence Consultation with regulatory/sector authority Designation of notified bodies Problem: not uniform assessments in member states Uneven quality Unfair competition Loss of confidence in the system Solution: harmonisation (revision of the New Approach, EA involvement) Market surveillance in Sweden The EEA Treaty 1993/94 State monopoly system replaced by “open” system of CA Transition from pre-market approval to market surveillance Existing sector authorities responsible for market surveillance Financing primarily through fees SWEDAC appointed as coordination and contact body Market surveillance authorities Authority The Swedish Work Environment Authority Product categories machinery, PPE (professional use), pressure equipment The National Board of Housing, Building and Planning construction products, lifts, hot water boilers The National Electrical Safety Board electrical products, EMC The National Chemicals Inspectorate poisonous gas in gas equipment, chemicals The National Consumer Agency GPSD, toys, PPE (private use) The National Medical Products Agency medical devices, medicines and associated products The Swedish Rail Agency trans-European conventional and high-speed rail systems The National Post and Telecom Agency radio and telecommunications terminal equipment The Swedish Radio and TV Authority electronic communications networks and services The Swedish Maritime Administration recreational crafts, marine equipment The Swedish Rescue Services Agency explosives, gas appliances, transportable pressure equipment The Swedish Environmental Protection Agency exhaust cleaning requirements for vehicles, noise emissions SWEDAC legal metrology, precious metals The National Road Administration motor vehicles, mobile machines Review of the Swedish system 10 years of experience New directive on general product safety Review of the New Approach 2003 Government Enquiry Commission 2005 Government Bill on Market Surveillance 2006 Ordinance on Market Surveillance Enquiry Commission Report Conclusions • • • • • • • Maintain existing organisation of sector authorities Higher political profile Overall objective of market surveillance in new regulation Stricter directions from government to authorities Enhanced coordination between authorities More active role for SWEDAC and the Market Surveillance Council Increased resources to authorities Government Bill Followed the main conclusions of the Commission proposals Strong political profile “Market surveillance should be conducted to the extent required to ensure that goods on the market fulfil the requirements.” No additional resources Ordinance on market surveillance • • • • • • In force since 1 January 2006 General definition of market surveillance Guidelines for market surveillance activities Clarification of responsibilities Requirement on cooperation and coordination of sector authorities Market Surveillance Council Ordinance on market surveillance Definition ”Measures by public authorities to ensure that a product made available on the market comply with existing requirements” Ordinance on market surveillance Guidelines The need for market surveillance shall be assessed for each product category, taking into account • characteristics of a product • risks associated with the product • results from previous market surveillance • foreseeable use • other authorities’ market surveillance activities Authorities shall coordinate their market surveillance activities when suitable The Market Surveillance Council • Representatives from sector authorities, Customs and the National Board of Trade • Industry and consumer organisations regularly invited • Secretariat at SWEDAC • 4-5 meetings/year The Market Surveillance Council • Forum for cooperation and exchange of experiences • Horisontal role of coordination • Action plan • Annual report to Government • Information to the public and industry Action Plan on Market Surveillance • Adopted by the Market Surveillance Council (Nov. 2005) • Replaces earlier annual reports from SWEDAC • More proactive • Focus on issues and problems common for all authorities • Suggests specific actions Action Plan on Market Surveillance • • • • • • • Clarify responsibilities for different product categories Develop methods for more efficient surveillance, e.g. risk assessment, systematic use of statistics. Investigate the possibility to use accredited conformity assessment bodies Explore more efficient means for information exchange Develop routines for cooperation between market surveillance and customs authorities Enhance consultations with industry Increase information to industry and public, e.g. education, common website Swedish Board for Accreditation and Conformity Assessment For more information www.swedac.se